Bending resistant male connector for a guide wire

ABSTRACT

During use there is a risk that a male connector for a guide wire is bent. With the present male connector ( 1 ) more material with high modulus of elasticity can be provided inside the male connector ( 1 ), which makes the male connector ( 1 ) more bending resistant. The male connector ( 1 ) comprises a core wire ( 3 ), a plurality of conductive members ( 4 ) spaced apart longitudinally along said core wire ( 3 ), a plurality of conductors ( 5 ) disposed along the core wire ( 3 ), each of the conductors ( 5 ) being connected to a respective conductive member ( 4 ). The connector ( 1 ) has such a configuration that the conductors ( 5 ) are protected from damage at the location where the conductors ( 5 ) connect to the conductive members ( 4 ).

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/831,650, filed Jul. 7, 2010, which is a continuation application ofU.S. application Ser. No. 10/812,914, filed Mar. 31, 2004, now U.S. Pat.No. 7,775,992, which is a divisional application of U.S. applicationSer. No. 09/986,117, filed Nov. 7, 2001, now U.S. Pat. No. 6,908,442,the contents of which are incorporated herein in their entirety.

FIELD OF THE INVENTION

The present invention relates to a bending resistant male connector fora guide wire, and in particular to a bending resistant male connectorhaving a core wire with such a shape that the total configurationconsisting of the core wire, conductors and insulating material makes anoptimal use of the available space inside the male connector.

BACKGROUND OF THE INVENTION

Guide wires are generally known in the art. They are, for example, usedin connection with the treatment of coronary diseases, where an x-ray ofa blood vessel may be done to detect the presence of an occlusion,which, however, does not show the cross section of a stenosis. It isaccepted that the best way to diagnose the significance of the stenosisis to perform a measurement of the blood pressure upstream anddownstream of the stenosis. In this case, a guide wire is used toposition a pressure-measuring sensor in the area of interest. Once theguide wire is positioned, a catheter is slid over the guide wire and aballoon dilation may then be done. The electrical signals from thepressure-measuring sensor at the distal end of the guide wire are leadthrough conductors embedded in the guide wire to a male connector at theproximal end of the guide wire. In use, the male connector is connectedto a female connector and the signals from the pressure-measuring sensorare transferred to an interface, which converts the signals and presentsthem in the desired form for an operator.

The male connector disposed at the proximal end of the guide wirecomprises basically a core wire, a plurality of conductors, a pluralityof conductive members, and insulating material therebetween. When themale connector is connected to the female connector, the conductivemembers transfer the electrical signals from the conductors of the maleconnector to similar conductive members inside the female connector. Thecore wire, which conventionally extends through the guide wire, is usedto prevent kinks, to provide strength to the guide wire and to hold theguide wire together. Especially when the male connector is inserted intothe female connector, there exists a substantial risk of over-bendingthe male connector or damaging the thin conductors inside the maleconnector. The core wire inside the male connector is therefore normallymade of a material with high modulus of elasticity, such as stainlesssteel. Examples of such male connectors are disclosed in U.S. Pat. No.5,178,159 and U.S. Pat. No. 5,938,624.

From the above, it should be obvious that the core wire should be aslarge as possible, so that a large amount of high strength material isprovided inside the male connector, while leaving enough room for theconductors and insulation to fit within the guide wire. In U.S. Pat. No.5,178,159 and U.S. Pat. No. 5,938,624 it is assumed that the core wireis cylindrical and that the conductors are disposed at the outside ofthe core wire. With this shape of the core wire, the total configurationconsisting of the core wire and the conductors will occupy a large partof the space inside the male connector, without the core wire and thethin conductors themselves actually utilizing an optimum of theavailable space, or, with other words, there is an excess of insulatingmaterial inside the male connector. Here it should be mentioned that theavailable space inside the guide wire is limited by the diameter of thecatheter that is slid over the guide wire. Since the catheter also isslid over the male connector, which extends from the proximal end of theguide wire, the size of the entire male connector is also limited by thediameter of this catheter. The nominal diameter of a conventional smallcatheter may be as small as 0.355 mm, which provides an upper limit forthe diameter of a male connector used together with such a catheter.

As mentioned above, the core wire conventionally extends through theguide wire, all the way from the sensor at the distal end of the guidewire to the male connector at the proximal end of the guide wire, wherethe core wire provides stiffness to the male connector. For such a longcore wire, the most economical and practical shape of the core wire iscylindrical, and the conventional thinking has been to keep thecylindrical shape of the core wire also inside the male connector,despite the disadvantage that the total configuration consisting of thecore wire and the conductors occupies less than the optimum of theavailable space, which involves the risk that the male connector will bebent or damaged when inserted into the female connector.

Consequently, there exists a need for a male connector having a corewire with such a shape that the total configuration consisting of thecore wire, conductors and insulating material makes an optimal use ofthe available space inside the male connector. In order to keep thecylindrical shape of the part of the core wire that extends from themale connector to the sensor, the male connector should preferablyconstitute a separate unit, which can be mounted at the proximal end ofan existing guide wire. Obviously, the last requirement implies that thecore wire inside the male connector is different from the core wireinside the rest of the guide wire.

SUMMARY OF THE INVENTION

The main object of the present invention is to provide a male connectorhaving a core wire with such a shape that more material with highmodulus of elasticity can be provided inside the male connector, whilestill leaving enough space for the conductors.

A second object of the present invention is to provide a male connectorwhich is durable and resistant against bending, and which is easy toinsert into a female connector without bending.

A third object of the present invention is to provide a male connectorhaving a core wire with such a shape that the conductors are protectedfrom damage even if the male connector is bent.

A fourth object of the present invention is to provide a male connectorthat allows a long insulation distance between the conductive memberswith preserved stiffness.

A fifth object of the present invention is to provide a male connectorthat is separately mountable on an existing guide wire.

A sixth object of the present invention is to provide a male connectorthat allows filling of insulation material with a minimum of voids,which yields a waterproof and constant quality design.

These objects are achieved with a male connector as defined in claim 1.Preferred embodiments of the male connector according to the inventionare defined in the dependent claims.

A preferred embodiment of the male connector according to the presentinvention comprises a core wire, a plurality of conductive members, aplurality of conductors, and insulating material. Each of the conductorsis connected to a respective conductive member. The conductive members,which are annular with the same outer diameter as the guide wire, arespaced apart longitudinally from each other. The core wire is notcylindrical, but a part of its mantel surface is flat, thereby givingthe core wire a D-shaped cross section.

When the male connector is assembled, the conductors are positionedoutside the straight leg of the D-shaped cross section. When the maleconnector has been attached to the proximal end of a guide wire and theD-shaped core wire has been inserted a small distance into the guidewire, the conductors at the distal end of the male connector aretherefore positioned in the elongated cavity created between the innersurface of the cylindrical guide wire and the D-shaped core wire. Themore proximal sections of the conductors that are inside the annularconductive members are in the corresponding way positioned in thecavities created between the conductive members and the D-shaped corewire.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a male connector according to the present inventionmounted on a guide wire.

FIG. 2 illustrates the male connector of FIG. 1 provided with extrainsulating material.

FIG. 3 illustrates a guide wire with a male connector used within acatheter, and a female connector connected to a monitor.

FIG. 4 shows the cross section of a male connector according to priorart.

FIG. 5 shows the cross section of a first embodiment of a male connectoraccording to the present invention.

FIG. 5 a shows an enlarged part of the core wire of FIG. 5.

FIG. 5 b shows an enlarged part of the conductors of FIG. 5.

FIG. 6 shows the cross section of a second embodiment of a maleconnector according to the present invention.

FIG. 7 shows the cross section of a third embodiment of a male connectoraccording to the present invention.

FIG. 8 shows the cross section of a fourth embodiment of a maleconnector according to the present invention.

FIG. 9 illustrates a male connector having an alternative conductorconfiguration.

FIG. 10 shows the cross section of the male connector according to FIG.9.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a male connector 1 according to the presentinvention. The male connector 1 is disposed on the proximal end of aguide wire 2. The male connector 1 comprises basically a core wire 3, aplurality of conductive members 4, and plurality of conductors 5.

The conductive members 4, which are annular with the same outer diameteras the guide wire 2, are spaced apart longitudinally from each other.When the male connector 1 is assembled, each of the conductors 5 iselectrically connected to a respective conductive member 4 andinsulating material 6 is provided between the core wire 3 and theconductive members 4. The insulating material 6 fixates the conductors 5inside the conductive members 4 and insulates the conductive members 4from the core wire 3.

In FIG. 2, the male connector 1 of FIG. 1 has been provided with anextra continuous outer insulating material 7, the outer surface of whichbeing coextensive with the outer surfaces of the conductive members 4.The insulating material 7 insulates the conductors 5 and the conductivemembers 4 from each other, and provides the male connector withadditional stiffness.

Note that in FIGS. 1 and 2 there is a small gap provided between thecore wire 3 of the male connector 1 and the core wire that extendsthrough the rest of the guide wire 2, i.e. the core wire 3 of the maleconnector 1 is not an integral part of the core wire in the more distaland much longer part of the guide wire 2 that is not shown in FIG. 1 orFIG. 2. Consequently, this small gap indicates that the male connector 1can be regarded as a separate part of the overall guide wire assembly,which is in contrast to the prior art designs. The special advantageswith this feature will be described below.

From FIG. 1 and FIG. 2 it should be noted that the proximal end of aconductor 5 is connected the proximal end of the correspondingconductive member 4, i.e. the adjacent proximal part of the conductor 5is supported by the conductive member 4 and the insulating material 6inside this conductive member 4. The conductive members 4 are relativelystiff, and, when the male connector 1 is bent, the connections betweenthe conductive members 4 and the conductors 5 are therefore experiencingless bending stress than they would do if the conductors 5 were attachedto the distal ends of the conductive members 4.

The overall guide wire assembly is illustrated in FIG. 3, where a maleconnector 1 is attached to the proximal end of a guide wire 2. The guidewire 2 is inserted within a balloon catheter 8. At the distal end of theguide wire 2 is a sensor 9. The male connector 1 is inserted into afemale connector 10. The female connector 10 is electrically connectableinto a monitor device 11. In practise, the distal end of the guide wire2 is inserted into the body, for example into an opening into thefemoral artery. Once positioned by a physician at the appropriatelocation, a catheter 8 of the desired type is guided onto the guide wire2. In use, the signals from the sensor 9 are lead by the conductorsenclosed in the guide wire 2 to the conductive members of the maleconnector 1. The signals are then transferred from the conductivemembers of the male connector 1 to similar conductive members inside thefemale connector 10. The signals are then presented for the physician bythe monitor device 11.

FIG. 4 shows the cross section of a male connector according to a priorart design. In this case, three conductors are symmetrically disposedaround a cylindrical core wire positioned eccentrically in the maleconnector. A conductive member surrounds the core wire and the threeconductors, and insulating material fills the rest of the space insidethe male connector. A major disadvantage with such a prior art design isthat if the male connector illustrated in FIG. 4 is bent, for instanceduring insertion into a female connector, all parts of the maleconnector will experience a bending stress. In this case, the thin andsensitive conductors embedded in the relatively soft insulating materialmay be squeezed between the harder core wire and conductive member,which involves the risk that one or several of these conductors will bedamaged or break.

In FIG. 5 the cross section of a preferred embodiment of a maleconnector according to the present invention is illustrated. In thiscase, a core wire 3 having a homogenous D-shaped cross sectionconstitutes the central part of a male connector. In this case, threeconductors 5 are positioned outside the flat part of the D-shaped corewire 3, and a cylindrical conductive member 4 surrounds the conductors 5and the D-shaped core wire 3. The rest of the space inside thecylindrical conductive member 4 is filled with insulating material 6,with a minimum of insulating material 6 being provided between theconductive member 4 and the curved part of the D-shaped core wire 3.

It should be noted that the D-shape of the core wire 3 provides a cavitybetween the inner surface of the cylindrical conductive member 4 and theflat part of the D-shaped core wire 3. This cavity, in which theconductors 5 are disposed, will remain practically intact even when themale connector is bent. This means that even if a bending stress isimposed on the male connector, there is no risk that the conductors 5will be squeezed between the core wire 3 and the conductive member 4,which obviously prevents the conductors 5 from being damaged during, forexample, insertion into a female connector. From FIG. 5 it should beobvious that a requirement for such a protecting cavity is that the endsof the straight leg of the D-shaped cross section are positioned nearthe conductive member 4, i.e. there is a minimum of insulating material6 between the inner surface of the conductive member 4 and these partsof the D-shaped core wire 3. Note that herein, the term “cavity” shouldnot be taken literally. As is apparent from FIG. 5, also the cavity isfilled with the continuous insulating material 6.

An enlarged part of the core wire 3 of FIG. 5 is illustrated in FIG. 5a. FIG. 5 a shows that the core wire 3 is provided with a separate layerof insulating material 12. The core wire 3 may therefore be regarded asan insulated core wire 3, and the amount of insulating material 6 beingprovided between the curved part of the D-shaped core wire 3 and theconductive member 4 can practically be reduced to zero. An example ofsuch an insulating material 12 is ceramic particles contained in apolymer matrix. As an alternative, the insulating material 12 canconsist of a metal oxidized to ceramic state. For instance, the corewire 3 could be made of titanium, the surface of which is oxidized totitanium dioxide, or the core wire 3 could be made of a metal having acoating of aluminium oxidized to Al₂O₃. It is also possible tomanufacture the core wire 3 from an insulating material, in which caseno insulating material has to be provided between the curved part of theD-shaped core wire 3 and the conductive members 4. With the properchoice of material for the core wire 3 and/or the insulating material12, the conductors 5 may be connected to the conductive members 4 by acrimping technique.

In FIG. 5 b an enlarged part of the conductors 5 of FIG. 5 isillustrated. FIG. 5 b shows that the conductors 5 each are provided witha separate layer of insulating material 13. The conductors 5 maytherefore be regarded as insulated conductors 5, which means thatconductors 5 may be positioned very close to each other, i.e. withoutinsulating material 6 being provided between them.

As mentioned above, the conventional design of a male connector for aguide wire is to let the core wire extend into the male connector, i.e.the core wire of the male connector is an integral part of the core wirein the guide wire. As an example, since the guide wire may be ratherlong and thin, up to 300 cm long and 0.355 mm in diameter, it seemspractical and economical to have a cylindrical core wire inside theguide wire. The core wire in such a conventional 0.355 mm guide wire hastypically a diameter of only 0.15 mm. To let such a thin cylindricalcore wire extend into a male connector and simply flatten a part of themantle surface of the core wire in order to create a D-shaped crosssection would not provide the special advantages described above. Thisfact is easy to recognize from FIG. 4, where a core wire according to aconventional design is illustrated. To just strip off a part of themantle surface of a core wire having such a small diameter wouldobviously not create a cavity in which the conductors could residewithout the risk of being damaged when the male connector is bent.Although it is conceivable, and within the scope of the presentinvention, to enlarge the part of the core wire that extends into themale connector and form this part into the desired cross section, suchas a D-shaped cross section, a better solution is to provide maleconnector which is separately mountable on an existing guide wire.

In FIG. 6 the cross section of a first alternative embodiment of themale connector according to the present invention is illustrated. Inthis embodiment, the core wire 3 has been provided with a trough-shapedrecess, in which the conductors 5 are accommodated. The cavity createdby this trough-shaped recess would obviously protect the conductors 5from being squeezed between the conductive member 4 and the core wire 3if the male connector is bent.

In FIG. 6, the conductors 5 are all positioned in a common cavitycreated by a single recess in the mantle surface of the core wire 3.However, each of the connectors 5 could be positioned in a separatecavity. This type of configuration is illustrated in FIG. 7, where threerecesses are provided in the mantle surface of the core wire 3. Each ofthese three recesses accommodates a single conductor 5.

As mentioned above, the main object of the present invention is toprovide a male connector having a core wire with such a shape that alarge amount of material with high modulus of elasticity can be providedinside the male connector, so that core wire, and therefore the maleconnector, is as stiff as possible. In accordance with this object, itis also conceivable to replace the recesses described above with one orseveral longitudinal holes, in which the conductors are disposed. Anexample of such a configuration is shown in FIG. 8, where the core wire3 has been provided with a cavity in the form of a central hole, inwhich the conductors 5 are accommodated.

From the illustrated embodiments of the present invention it should beobvious that from a manufacturing point of view the conductive members 4may be regarded as resting against the core wire 3, since at least twopoints on the mantle surface of the core wire 3 have such positions thatthere is only one way to radially position the core wire 3 inside theconductive member 4. The core wire 3 may therefore be described as aself-centering or self-positioning core wire 3, and, consequently, noextra positioning step is necessary in the manufacturing of the presentmale connector 1. From FIG. 4 it should be obvious that this advantageis in contrast to prior art designs, in which the core wire has to becarefully positioned in the centre of the conductive member, or at someother location inside the conductive member.

In FIG. 9 a male connector 1 with another configuration of theconductors 5 is illustrated. In the depicted configuration, each of theconductors 5 is drawn in a 180° loop before being connected to therespective conductive member 4. Tests have shown that this loop, whichextends in the proximal direction of the male connector 1 before goingback to the distal end of the conductive member 4, where the conductor 5is connected, further improves the durability of the conductors 5.Especially when the conductor arrangement according to FIG. 9 iscombined with one of the core wire cross sections described above asurprisingly bending insensitive male connector is provided.

A cross section of the conductor arrangement of FIG. 9 will obviouslyexhibit an extra conductor cross section, since each conductor loopcontains two conductors, one going in the forward direction and onegoing in the backward direction. An example of such a cross section isshown in FIG. 10, where the D-shaped core wire according to FIG. 5 hasbeen combined with the conductor arrangement according to FIG. 9. Inthis case, the three conductors 5 give rise to four conductorcross-sections inside the conductive member 4.

To summarize, with the present male connector, which has such a designthat the total configuration consisting of the core wire and theconductors presents a substantially circular cross section, morematerial with high modulus of elasticity can be provided in the interiorof the male connector, in comparison with prior art designs. Thisfeature makes the male connector according to the invention durable andresistant against bending, which, in turn, makes it easy to insert themale connector into a female connector, with a minimum risk of bendingthe male connector and thereby damaging the conductors or other parts ofthe male connector.

Further, with a larger amount of material with high modulus ofelasticity, the male connector becomes stiffer, which allows a longinsulation distance between the longitudinally spaced apart annularconductive members with preserved stiffness. This is an advantage sincea long insulation distance means that the risk of leakage currentsbetween the conductive members is minimized.

Still further, with a larger amount of material with high modulus ofelasticity, the amount of insulating material inside the male connectorbecomes less, which allows filling of insulation material with a minimumof voids, which, in turn, yields a waterproof and constant qualitydesign.

Although the present invention has been described with reference tospecific embodiments, also shown in the appended drawings, it will beapparent for those skilled in the art that many variations andmodifications can be done within the scope of the invention as describedin the specification and defined in the following claims.

1.-20. (canceled)
 21. A guide wire assembly, comprising: a maleconnector including a metal core wire, a plurality of circular-shapedconductive members spaced apart longitudinally along the core wire anddefining a central longitudinal axis of the male connector, a pluralityof conductors disposed along the core wire, the conductors beingconnected to respective conductive members, and insulating material,wherein, at least one point along the length of the male connector, athickness of the core wire in the male connector, measured along linesthat pass through the central longitudinal axis of the male connector,is 47% or more of the diameter of the circular-shaped conductivemembers.
 22. A guide wire assembly as set forth in claim 21, furthercomprising a circular-shaped sleeve of insulating material between thecore wire and the plurality of circular-shaped conductive members.
 23. Aguide wire assembly as set forth in claim 21, wherein the core wire ismade from titanium.
 24. A guide wire assembly as set forth in claim 21,wherein the core wire is coated with titanium dioxide.
 25. A guide wireassembly as set forth in claim 21, wherein the core wire is coated withoxidized aluminum.
 26. A guide wire assembly as set forth in claim 21,wherein the core wire is generally cylindrically shaped.
 27. A guidewire assembly as set forth in claim 21, wherein the core wire isD-shaped.
 28. A guide wire assembly as set forth in claim 21 wherein, atleast one point along the length of the male connector, a thickness ofthe core wire in the male connector, measured along lines that passthrough the central longitudinal axis of the male connector, is 53% ormore of the diameter of the circular-shaped conductive members.
 29. Aguide wire assembly as set forth in claim 21, wherein the core wire inthe male connector contains at least one groove to accommodate at leastone conductor.
 30. A guide wire assembly as set forth in claim 21,wherein the core wire inside the male connector has a flat surface. 31.A guide wire assembly as set forth in claim 21, wherein the guide wireassembly comprises a second core wire distal of said core wire, thesecond core wire and said core wire being separated by a longitudinalgap.
 32. A guide wire assembly as set forth in claim 21, wherein atleast one point along the length of the male connector, at least onethickness of the core wire, measured along a line that passes throughthe central longitudinal axis of the male connector, is less than 100%of another thickness measured along a line that passes through thecentral longitudinal axis of the male connector.
 33. A guide wireassembly as set forth in claim 21 wherein, at least one point along thelength of the male connector, a thickness of the core wire in the maleconnector, measured along lines that pass through the centrallongitudinal axis of the male connector, is 58% or more of the diameterof the circular-shaped conductive members.